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Date Content
30/05/2023 Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 21, Authorised (updated)
26/05/2023 Human medicines European public assessment report (EPAR): Cinqaero, Reslizumab, Asthma, 15/08/2016, 11, Authorised (updated)
26/05/2023 Human medicines European public assessment report (EPAR): Procysbi, mercaptamine bitartrate, Cystinosis, 05/09/2013, Orphan, 16, Authorised (updated)
26/05/2023 Focus group meeting on bacteriophages as veterinary medicines , Online, 09:30-16:30 CEST (Amsterdam time), from 11/05/2023 to 11/05/2023 (updated)
26/05/2023 Human medicines European public assessment report (EPAR): Ogluo, Glucagon, Diabetes Mellitus, 11/02/2021, 5, Authorised (updated)
26/05/2023 ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3 - Public Consultation , Online 13 July- 13:30 - 18:10 (CEST); European Medicines Agency, Amsterdam, the Netherlands, from 13/07/2023 to 14/07/2023 (updated)
26/05/2023 Quarterly system demo - Q2 2023 , Online, 09:00 - 13:00 Amsterdam time (CEST), from 22/06/2023 to 22/06/2023
26/05/2023 News and press releases: EMA business hours over Whit Monday, 29 May
26/05/2023 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy; Anxiety Disorders; Neuralgia, 05/07/2004, 60, Authorised (updated)
26/05/2023 Human medicines European public assessment report (EPAR): Xigduo, metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 16/01/2014, 20, Authorised (updated)
26/05/2023 Withdrawn application: Asimtufii, aripiprazole, Date of withdrawal: 02/05/2023, Initial authorisation
26/05/2023 Summary of opinion: Pylclari, piflufolastat (18F), 25/05/2023, Positive
26/05/2023 Withdrawn application: Susvimo, ranibizumab, Date of withdrawal: 02/05/2023, Initial authorisation
26/05/2023 Summary of opinion: Sogroya, somapacitan, 26/05/2023, Positive
26/05/2023 Summary of opinion: Ztalmy, ganaxolone, 26/05/2023, Positive
26/05/2023 Summary of opinion: Opdivo, nivolumab, 25/05/2023, Positive
26/05/2023 Scientific guideline: Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b
26/05/2023 Summary of opinion: Sohonos, palovarotene, 26/01/2023, Negative (updated)
26/05/2023 ICH E6 (R2) Good clinical practice - Scientific guideline (updated)
26/05/2023 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023
26/05/2023 Big data (updated)
26/05/2023 Human medicines European public assessment report (EPAR): Beovu, brolucizumab, Wet Macular Degeneration, 13/02/2020, Additional monitoring, 8, Authorised (updated)
26/05/2023 Summary of opinion - Initial authorisation: CHMP summary of positive opinion for Pylclari
26/05/2023 Withdrawal letter: Withdrawal letter: Asimtufii
26/05/2023 News and press releases: EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo
26/05/2023 Medicine QA: Questions and answers on the withdrawal of application for the marketing authorisation of Asimtufii (aripiprazole)
26/05/2023 Referral: Adakveo , crizanlizumab, Article 20 procedures, Opinion provided by Committee for Medicinal Products for Human Use, 25/05/2023, 26/05/2023 (updated)
26/05/2023 Summary of opinion: CHMP post-authorisation summary of positive opinion for Opdivo (II-117)
26/05/2023 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023 (updated)
26/05/2023 Report: Human medicines highlights 2022 (updated)
26/05/2023 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
26/05/2023 Minutes: Minutes of the CVMP meeting of 18-20 April 2023
25/05/2023 Human medicines European public assessment report (EPAR): Ixiaro, Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese; Immunization, 31/03/2009, 17, Authorised (updated)
25/05/2023 Supply shortage: Shortage of Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
25/05/2023 COVID-19: latest updates (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Breyanzi, CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms, 04/04/2022, Additional monitoring, 1, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Livmarli, Maralixibat chloride, Alagille Syndrome, 09/12/2022, Orphan, Additional monitoring, Exceptional circumstances, 1, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Galafold, Migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 16, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), 6-mercaptopurine monohydrate, Leukemia, Lymphoid, 09/03/2012, 15, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Sustiva, efavirenz, HIV Infections, 28/05/1999, 48, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis, 26/09/2017, 26, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 17, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Olumiant, Baricitinib, Arthritis, Rheumatoid, 13/02/2017, Patient safety, 13, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosilate, Stroke; Venous Thromboembolism, 19/06/2015, 16, Authorised (updated)
25/05/2023 Extended EudraVigilance medicinal product dictionary (XEVMPD) training (updated)
25/05/2023 Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - November 2023 , Online, 09:00 - 13:00 Amsterdam time (CET) , from 30/11/2023 to 01/12/2023
25/05/2023 Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - October 2023 , Online, 09:00 - 13:00 Amsterdam time (CET) , from 19/10/2023 to 20/10/2023
25/05/2023 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November 2023 , Online, 09:00 - 13:00 Amsterdam time (CET), from 27/11/2023 to 29/11/2023
25/05/2023 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - October 2023 , Online, 09:00 - 13:00 Amsterdam time (CET), from 16/10/2023 to 18/10/2023
25/05/2023 Human medicines European public assessment report (EPAR): Elfabrio, Pegunigalsidase alfa, Fabry Disease, 04/05/2023, 1, Authorised (updated)
25/05/2023 Scientific recommendations on classification of advanced therapy medicinal products (updated)
25/05/2023 Other: Guide on access to unpublished documents (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin diphosphate, Soft Tissue Infections; Skin Diseases, Bacterial, 19/03/2015, 12, Authorised (updated)
25/05/2023 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Orkambi, Lumacaftor, ivacaftor, Cystic Fibrosis, 18/11/2015, 31, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Trisenox, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 05/03/2002, 31, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Fasenra, Benralizumab, Asthma, 08/01/2018, 10, Authorised (updated)
25/05/2023 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - September 2023 , Online, 14:00 - 18:00 Amsterdam time (CET), from 20/09/2023 to 22/09/2023
25/05/2023 Availability of medicines (updated)
25/05/2023 HMA/EMA multi-stakeholder workshop on shortages , Online, 09:00 - 16:45 Amsterdam time (CET), from 01/03/2023 to 02/03/2023 (updated)
25/05/2023 Report: Report - Moving together towards better prevention of medicine shortages in the EU
25/05/2023 Clinical Trials Regulation: progress on implementation (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 29/05/2006, Additional monitoring, Exceptional circumstances, 33, Authorised (updated)
25/05/2023 Work Instruction - WIN: Work instructions for key activities when screening the electronic reaction monitoring reports (eRMRs) for new signals
25/05/2023 Human medicines European public assessment report (EPAR): Nexviadyme, Avalglucosidase alfa, Glycogen Storage Disease Type II, 24/06/2022, Additional monitoring, 2, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir, ritonavir, HIV Infections, 14/01/2016, Generic, 16, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 15, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic, 19/09/2019, Orphan, 14, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, 19, Authorised (updated)
25/05/2023 Other: List of eligible industry stakeholder organisations (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Myocardial Perfusion Imaging, 06/09/2010, 15, Authorised (updated)
25/05/2023 Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, 23/03/2018, Orphan, Additional monitoring, 10, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Somac Control, pantoprazole, Gastroesophageal Reflux, 12/06/2009, 16, Authorised (updated)
24/05/2023 Modelling and simulation: questions and answers (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, 30, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Byetta, exenatide, Diabetes Mellitus, Type 2, 20/11/2006, 28, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Twinrix Adult, hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B; Hepatitis A; Immunization, 19/09/1996, 23, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Synflorix, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal Infections; Immunization, 29/03/2009, 36, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Infanrix Hexa, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, 23/10/2000, 46, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Fendrix, hepatitis B surface antigen, Hepatitis B; Immunization, 02/02/2005, 12, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 15/09/2008, Biosimilar, 17, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Ambirix, hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B; Hepatitis A; Immunization, 30/08/2002, 17, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Volibris, ambrisentan, Hypertension, Pulmonary, 20/04/2008, 23, Authorised (updated)
24/05/2023 Healthcare Professionals' Working Party (updated)
24/05/2023 Periodic safety update single assessment: Etidronate : List of nationally authorised medicinal products - PSUSA/00001320/202209
24/05/2023 Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, 26/11/2012, 25, Authorised (updated)
24/05/2023 Periodic safety update single assessment: Etomidate : List of nationally authorised medicinal products - PSUSA/00001330/202209
24/05/2023 Periodic safety update single assessment: Felbamate : List of nationally authorised medicinal products - PSUSA/00010155/202209
24/05/2023 Human medicines European public assessment report (EPAR): Renagel, sevelamer, Renal Dialysis; Hyperphosphatemia, 28/01/2000, 35, Authorised (updated)
24/05/2023 Human medicines European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), sevelamer carbonate, Hyperphosphatemia; Renal Dialysis, 15/01/2015, 21, Authorised (updated)
24/05/2023 Union Product Database (updated)
24/05/2023 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (updated)
24/05/2023 Clinical Trials Information System (CTIS): Walk-in clinic - May 2023 , Online, 16:00 - 17:00 Amsterdam time (CEST), from 17/05/2023 to 17/05/2023 (updated)
24/05/2023 EMA multi-stakeholder workshop on qualification of novel methodologies , Online, from 17/04/2023 to 18/04/2023 (updated)
24/05/2023 ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline (updated)
24/05/2023 Overview of comments: Overview of comments received on ICH M11 template
24/05/2023 Overview of comments: Overview of comments received on ICH M11 technical specification
24/05/2023 Overview of comments: Overview of comments received on ICH M11 guideline, clinical study protocol template and technical specifications
24/05/2023 Minutes: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (20 April 2023)
23/05/2023 Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Diabetes Mellitus, 23/03/2018, Additional monitoring, Biosimilar, 8, Authorised (updated)
23/05/2023 Minutes: Minutes of the HMPC 13-15 March 2023 meeting
23/05/2023 Agenda: Agenda of the PDCO meeting 23-26 May 2023
23/05/2023 Report: Medicinal products for human use: monthly figures - April 2023
23/05/2023 Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 07/06/2010, Biosimilar, 27, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Kirsty (previously Kixelle), insulin aspart, Diabetes Mellitus, 05/02/2021, Additional monitoring, Biosimilar, 2, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Flucelvax Tetra, A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human, 12/12/2018, Additional monitoring, 13, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Heplisav B, hepatitis B surface antigen, Hepatitis B, 18/02/2021, Additional monitoring, 3, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, 13/07/2011, Additional monitoring, 30, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, 28/03/2019, Additional monitoring, 9, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Darunavir Mylan, darunavir, HIV Infections, 03/01/2017, Generic, 13, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections; Uterine Cervical Dysplasia; Immunization, 20/09/2007, 39, Authorised (updated)
23/05/2023 Human medicines European public assessment report (EPAR): Bexsero, outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal, 13/01/2013, 32, Authorised (updated)
22/05/2023 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing, 14/01/2015, 31, Authorised (updated)
22/05/2023 Clinical Data Publication (Policy 0070) re-launch - EMA webinar , Online, 15:30 - 17:00 Amsterdam time (CEST), from 16/05/2023 to 16/05/2023 (updated)
22/05/2023 Human medicines European public assessment report (EPAR): Fluad Tetra, A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human, 20/05/2020, Additional monitoring, 6, Authorised (updated)
22/05/2023 Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, Additional monitoring, 1, Authorised (updated)
22/05/2023 News and press releases: Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects (updated)
22/05/2023 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023 (updated)
22/05/2023 Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 24, Authorised (updated)
22/05/2023 Clinical Trials Information System Webinar: Second Year of Transition , Online, 13:00 - 17.30 Amsterdam time (CET), from 04/07/2023 to 04/07/2023 (updated)
22/05/2023 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023
22/05/2023 Scientific publications (updated)
22/05/2023 Maximum Residue Limits - Summary of opinion: Ketoprofen (poultry) - Summary opinion of the CVMP on the extension of maximum residue limits (updated)
22/05/2023 Human medicines European public assessment report (EPAR): Ibrance, Palbociclib, Breast Neoplasms, 09/11/2016, Additional monitoring, 15, Authorised (updated)
22/05/2023 Referral: Janus kinase inhibitors (JAKi) , tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, Article 20 procedures, European Commission final decision, 23/01/2023, 10/03/2023, 22/05/2023 (updated)
22/05/2023 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2023 work plan , Online, from 28/02/2023 to 01/03/2023 (updated)
22/05/2023 Other: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when (updated)
22/05/2023 CVMP Interested Parties’ meeting , European Medicines Agency, Amsterdam, the Netherlands, 10:00-12:00 CEST (Amsterdam time), from 24/05/2023 to 24/05/2023 (updated)
22/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one, PM: decision on the application for modification of an agreed PIP, P/0312/2020 (updated)
22/05/2023 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Derivative of 4Hpyrazolo[3,4-d]pyrimidin-4-one (BI409306) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
22/05/2023 Liposomal amphotericin B product-specific bioequivalence guidance (updated)
22/05/2023 ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - Scientific guideline (updated)
22/05/2023 Scientific guideline: ICH S5 (R3) guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - step 5 - Revision 4 (updated)
22/05/2023 Other: EVVet3 EVWeb Production – Release notes (updated)
22/05/2023 Minutes: Minutes of the CHMP meeting 27-30 March 2023
22/05/2023 Scientific guideline: VICH GL42: Pharmacovigilance: data elements for submission of adverse event reports (AERs) (updated)
22/05/2023 Agenda: Agenda of the CHMP meeting 22-25 May 2023
22/05/2023 What we publish on medicines and when (updated)
22/05/2023 Scientific guideline: VICH GL35: Pharmacovigilance: electronic standards for transfer of data (updated)
22/05/2023 Clinical Trials Information System (CTIS) bitesize talk: How to submit a transitional trial in CTIS , Online, 15:30 - 17:00 Amsterdam time (CEST), from 21/06/2023 to 21/06/2023 (updated)
22/05/2023 Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission , Online, 15:30 - 17:00 Amsterdam time (CEST), from 10/05/2023 to 10/05/2023 (updated)
17/05/2023 Other: Questions and answers on the protection of commercially confidential information and personal data while using CTIS (updated)
17/05/2023 SPOR and XEVMPD Week , Online, from 17/04/2023 to 20/04/2023 (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Circadin, melatonin, Sleep Initiation and Maintenance Disorders, 29/06/2007, 34, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Multiple Myeloma, 16/03/2016, 11, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Esbriet, Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases, 27/02/2011, 33, Authorised (updated)
17/05/2023 News and press releases: Guidance for industry to prevent and mitigate medicine shortages
17/05/2023 Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Diabetes Mellitus, Type 2, 23/08/2011, 19, Authorised (updated)
17/05/2023 PRAC: Agendas, minutes and highlights (updated)
17/05/2023 Minutes: Minutes of the PRAC meeting 6-9 February 2023
17/05/2023 Product Management Service (PMS) progress webinar , Online, 10:00 - 11:30 Amsterdam time (CEST), from 30/05/2023 to 30/05/2023 (updated)
17/05/2023 Work programme: Work programme until 2025 of the HMA/EMA task force on availability of authorised medicines for human and veterinary use (updated)
17/05/2023 Agenda: Agenda : Product Management Service (PMS) Progress Webinar
17/05/2023 Human medicines European public assessment report (EPAR): Kanuma, sebelipase alfa, Lipid Metabolism, Inborn Errors, 28/08/2015, Orphan, Accelerated assessment, Additional monitoring, 9, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Orphacol, cholic acid, Digestive System Diseases; Metabolism, Inborn Errors, 12/09/2013, 25/05/2012, Orphan, Additional monitoring, Exceptional circumstances, 13, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Hemlibra, Emicizumab, Hemophilia A, 23/02/2018, Accelerated assessment, 15, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 34, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 25/06/2020, Generic, 3, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, 09/11/2017, Generic, 14, Authorised (updated)
17/05/2023 Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages
17/05/2023 Listen-and-learn focus group meeting of the Quality Innovation Group , Online, from 13/03/2023 to 13/03/2023 (updated)
17/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Aztreonam (ATM),Avibactam (AVI), PM: decision on the application for modification of an agreed PIP, P/0185/2022 (updated)
17/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Betmiga, Mirabegron, PM: decision on the application for modification of an agreed PIP, P/0187/2022 (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, Additional monitoring, 14, Authorised (updated)
17/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, PM: decision on the application for modification of an agreed PIP, P/0180/2022 (updated)
17/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Libtayo, Cemiplimab, PM: decision on the application for modification of an agreed PIP, P/0179/2022 (updated)
17/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): ketamine (hydrochloride),sufentanil citrate, PM: decision on the application for modification of an agreed PIP, P/0177/2022 (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative, 22/01/2007, 42, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Atazanavir Mylan, atazanavir (as sulfate), HIV Infections, 22/08/2016, Generic, 14, Authorised (updated)
17/05/2023 Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 27/03/2013, 24, Authorised (updated)
17/05/2023 Plasma master file certificates (updated)
17/05/2023 Other: List of critical medicines for Monkeypox public health emergency (PHE) under Regulation (EU) 2022/123 (obsolete) (updated)
17/05/2023 Other: List of critical medicines for COVID-19 public health emergency (PHE) under Regulation (EU) 2022/123 (obsolete) (updated)
16/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tirzepatide, PM: decision on the application for modification of an agreed PIP, P/0174/2022 (updated)
16/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0175/2022 (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Pombiliti, Cipaglucosidase alfa, Glycogen Storage Disease Type II, 20/03/2023, Orphan, Additional monitoring, Authorised (updated)
16/05/2023 CHMP opinions on consultation procedures (updated)
16/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451), PM: decision on the application for modification of an agreed PIP, P/0168/2022 (updated)
16/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Remibrutinib, PM: decision on the application for modification of an agreed PIP, P/0170/2022 (updated)
16/05/2023 Other: Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (updated)
16/05/2023 Clinical Trials Information System (CTIS): Walk-in clinic - April 2023 , Online, 16:00 - 17:00 Amsterdam time (CEST), from 19/04/2023 to 19/04/2023 (updated)
16/05/2023 Template or form: QRD Appendix V - Adverse-drug-reaction reporting details (updated)
16/05/2023 Scientific and technical recommendations: Veterinary Medicines Regulation (updated)
16/05/2023 News and press releases: EMA business hours over Ascension Day holidays, 18 and 19 May
16/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, Cefiderocol, PM: decision on the application for modification of an agreed PIP, P/0163/2022 (updated)
16/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bis-choline tetrathiomolybdate, PM: decision on the application for modification of an agreed PIP, P/0164/2022 (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Diabetes Mellitus, Type 2, 22/05/2014, 27, Authorised (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Cinacalcet Accordpharma, cinacalcet hydrochloride, Hyperparathyroidism, 03/04/2020, Generic, 3, Authorised (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Febuxostat Mylan, febuxostat, Hyperuricemia; Arthritis, Gouty; Gout, 15/06/2017, Generic, 11, Authorised (updated)
16/05/2023 Periodic safety update single assessment: Aminosalicylic acid - List of nationally authorised medicinal products - PSUSA/00000165/202210
16/05/2023 Information Management (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Tarceva, erlotinib, Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms, 19/09/2005, 32, Authorised (updated)
16/05/2023 Other: Organisation chart: Information Management (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, 12, Authorised (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Sirturo, bedaquiline fumarate, Tuberculosis, Multidrug-Resistant, 05/03/2014, Orphan, Additional monitoring, Conditional approval, 21, Authorised (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Xofigo, radium (223Ra) dichloride, Prostatic Neoplasms, 13/11/2013, Additional monitoring, 13, Authorised (updated)
16/05/2023 Periodic safety update single assessment: Ambroxol / clenbuterol : List of nationally authorised medicinal products - PSUSA/00000131/202209
16/05/2023 Periodic safety update single assessment: Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/202209
16/05/2023 Human medicines European public assessment report (EPAR): Actelsar HCT, Telmisartan, hydrochlorothiazide, Essential Hypertension, 13/03/2013, Generic, 15, Authorised (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Revolade, Eltrombopag, Purpura, Thrombocytopenic, Idiopathic, 11/03/2010, 31, Authorised (updated)
16/05/2023 Human medicines European public assessment report (EPAR): Votrient, pazopanib, Carcinoma, Renal Cell, 14/06/2010, 31, Authorised (updated)
16/05/2023 Newsletter: CTIS newsflash - 12 May 2023
16/05/2023 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 45, Authorised (updated)
16/05/2023 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 47, Authorised (updated)
16/05/2023 Periodic safety update single assessment: Lysine acetylsalicylate : List of nationally authorised medicinal products - PSUSA/00001921/202209
15/05/2023 Newsletter: Electronic Application Form (eAF) - Product Management Service (PMS) newsletter - Issue 3
15/05/2023 Human medicines European public assessment report (EPAR): BiResp Spiromax, Budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma, 28/04/2014, 12, Authorised (updated)
15/05/2023 Agenda: Agenda of the CAT meeting 15-17 May 2023
15/05/2023 Agenda: Agenda of the CVMP meeting 15-17 May 2023
15/05/2023 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, 8, Authorised (updated)
15/05/2023 News and press releases: EMA annual report 2022 published
15/05/2023 Annual Report: 2022 annual report of the European Medicines Agency
15/05/2023 Annual Report: Annexes - 2022 annual report of the European Medicines Agency
15/05/2023 Annual Report: Annex 10 - 2022 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
15/05/2023 Annual reports and work programmes (updated)
15/05/2023 Periodic safety update single assessment: Trifarotene : List of nationally authorised medicinal products - PSUSA/00010929/202210
15/05/2023 Human medicines European public assessment report (EPAR): Bekemv, Eculizumab, Hemoglobinuria, Paroxysmal, 19/04/2023, Biosimilar, Authorised (updated)
15/05/2023 Product-information requirements (updated)
15/05/2023 Human medicines European public assessment report (EPAR): Rozlytrek, Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung, 31/07/2020, Additional monitoring, Conditional approval, 6, Authorised (updated)
15/05/2023 Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene), Pomalidomide, Multiple Myeloma, 05/08/2013, Orphan, Additional monitoring, 22, Authorised (updated)
15/05/2023 Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, Generic, 10, Authorised (updated)
12/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab, PM: decision on the application for modification of an agreed PIP, P/0166/2022 (updated)
12/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zebinix, eslicarbazepine acetate, PM: decision on the application for modification of an agreed PIP, P/0160/2022 (updated)
12/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): magnesium sulfate heptahydrate (BLI800),Sodium sulphate anhydrou,potassium sulfate, PM: decision on the application for modification of an agreed PIP, P/0159/2022 (updated)
12/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin, PM: decision on the application for modification of an agreed PIP, P/0161/2022 (updated)
12/05/2023 Webinar on Nationally Authorised Products (NAPs) release on Product Lifecycle Management (PLM) Portal electronic Application Forms (eAFs) , Online, 10:00 - 11:30 Amsterdam time (CEST), from 08/06/2023 to 08/06/2023
12/05/2023 Periodic safety update single assessment: Bromhexine : List of nationally authorised medicinal products - PSUSA/00000437/202209
12/05/2023 Periodic safety update single assessment: Terbinafine : List of nationally authorised medicinal products - PSUSA/00002896/202209
12/05/2023 Buying veterinary medicines online (updated)
12/05/2023 Periodic safety update single assessment: Artemether / lumefantrin (apart from the dispersible tablet) : List of nationally authorised medicinal products - PSUSA/00000236/202210
12/05/2023 Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), ChAdOx1-SARS-COV-2, COVID-19 virus infection, 29/01/2021, Patient safety, Additional monitoring, 28, Authorised (updated)
12/05/2023 Regulatory and procedural guideline: User guide on how to generate PDF versions of the product information - veterinary (updated)
12/05/2023 Referral: Pseudoephedrine-containing medicinal products , pseudoephedrine, Article 31 referrals, Under evaluation, 12/05/2023 (updated)
12/05/2023 Referral: Hydroxyprogesterone-containing medicinal products , hydroxyprogesterone, Lentogest,Progesterone Retard Pharlon,Proluton Depot, Article 31 referrals, Procedure started
12/05/2023 Human medicines European public assessment report (EPAR): TachoSil, human fibrinogen, human thrombin, Hemostasis, Surgical, 08/06/2004, 25, Authorised (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Retsevmo, Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms, 11/02/2021, Additional monitoring, Conditional approval, 6, Authorised (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Mounjaro, Tirzepatide, Diabetes Mellitus, Type 2, 15/09/2022, 2, Authorised (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Xerava, eravacycline, Infection; Bacterial Infections, 20/09/2018, Additional monitoring, 6, Authorised (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Evusheld, tixagevimab, cilgavimab, COVID-19 virus infection, 25/03/2022, Additional monitoring, 2, Authorised (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections, 13/12/2021, Additional monitoring, 4, Authorised (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Camcevi, leuprorelin mesilate, Prostatic Neoplasms, 24/05/2022, 1, Authorised (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Bylvay, Odevixibat, Cholestasis, Intrahepatic, 16/07/2021, Orphan, Accelerated assessment, Exceptional circumstances, 2, Authorised (updated)
12/05/2023 Orphan designation: Ivosidenib for the: Treatment of biliary tract cancer, 21/03/2018, Positive (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Tibsovo, Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma, 04/05/2023, Orphan, Additional monitoring, Authorised (updated)
12/05/2023 Orphan designation: Ivosidenib for the: Treatment of acute myeloid leukaemia, 12/12/2016, Positive (updated)
12/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, PM: decision on the application for modification of an agreed PIP, P/0157/2022 (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Pemazyre, pemigatinib, Cholangiocarcinoma, 26/03/2021, Orphan, Additional monitoring, Conditional approval, 5, Authorised (updated)
12/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept, PM: decision on the application for modification of an agreed PIP, P/0155/2022 (updated)
12/05/2023 Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib, PM: decision on the application for modification of an agreed PIP, P/0154/2022 (updated)
12/05/2023 Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary, 01/10/2008, 16, Authorised (updated)